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| Name | Class |
|---|---|
| Incozen Therapeutics Pvt Ltd | UNKNOWN |
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This is a randomized, double-blind, placebo-controlled study of RP7214 in patients with symptomatic mild SARS-CoV-2 infection, having at least one high-risk feature (e.g., age > 60 years, hypertension, diabetes mellitus, chronic lung disease, chronic kidney disease, liver disease, cerebrovascular disease, obesity, cancer) for developing severe Covid-19 illness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RP7214 + Standard of care (SOC) | Experimental |
| |
| Placebo + Standard of care (SOC) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RP7214 + Standard of care (SOC) | Drug | RP7214 tablets will be administered orally twice a day for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients requiring Covid-19 related hospitalization by Day 15. | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in SARS-CoV-2 viral load at Days 3, 7 and 15 by quantitative RT-PCR test | 15 days | |
| Time to symptom resolution in patients receiving RP7214 as compared to placebo | 15 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citizen Hospital | Bangalore | India | ||||
| Madhu Superspeciality Hospital & Research Center |
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| Placebo + Standard of care (SOC) | Drug | Placebo will be administered orally twice a for 14 days |
|
| Proportion of patients demonstrating symptom resolution |
| 15 days |
| Time to symptom improvement in patients receiving RP7214 as compared to placebo | 15 days |
| Proportion of patients demonstrating symptom improvement | 15 days |
| Adverse Events (AEs) as assessed by laboratory tests, vital signs and physical examination. | 15 days |
| Change in the disease-specific inflammatory markers (Ferritin, C-reactive protein (CRP), D-dimer, neutrophil to lymphocyte/CD8+ ratio, LDH, IL-6) as compared to baseline. | 15 days |
| Bangalore |
| India |
| Rajalakshmi Hospital & Research Center | Bangalore | India |
| Panimalar medical college hospital and research institute | Chennai | India |
| Maharaja Agrasen Superspeciality Hospital | Jaipur | India |
| Nil Ratan Sircar Medical College and Hospital | Kolkata | India |
| Malabar Medical College | Kozhikode | India |
| BAJ RR Hospital & Research center | Mumbai | India |
| DEC Healthcare Hospital | Nellore | India |
| Vijaya Super specialty Hospital | Nellore | India |
| Jivanrekha Multispeciality Hospital | Pune | India |
| PCMC'S PGI Yashwantrao Chavan Memorial Hospital | Pune | India |
| Sant Dnyaneshwar Hospital (Accord Multispeciality Hospital) | Pune | India |
| Govt General Hospital | Srikakulam | India |
| Great Eastern medical school and hospital | Srikakulam | India |
| King George Hospital | Visakhapatnam | India |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000718746 | RP7214 |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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